A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy
2 other identifiers
interventional
901
1 country
7
Brief Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2008
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
April 23, 2010
CompletedMay 9, 2014
April 1, 2014
8 months
January 31, 2008
October 2, 2009
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
48 hours
Secondary Outcomes (5)
Time to First Rescue Pain Medication Use.
3 days
The SPID at 12 Hours Relative to First Dose.
12 hours
SPID at 24 Hours Relative to First Dose
24 hours
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3
Baseline and 3 days
Total Pain Relief (TOTPAR)at 48 Hours
48 hours
Study Arms (4)
004
PLACEBO COMPARATORplacebo 1 capsule q4-6 hrs for 3 days
003
ACTIVE COMPARATORoxycodone 10mg capsule q4-6 hrs for 3 days
001
EXPERIMENTALTapentadol (CG5503) 50mg capsule q4-6 hrs for 3 days
002
EXPERIMENTALTapentadol (CG5503) 75mg capsule q4-6 hrs for 3 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients must undergo primary unilateral first metatarsal bunionectomy
- Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.
You may not qualify if:
- Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
- History of malignancy within the past 2 years before starting the study
- History of alcohol or drug abuse
- Evidence of active infections that may spread to other areas of the body
- Clinical laboratory values reflecting severe renal insufficiency
- Moderately or severely impaired hepatic function
- Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Glendale, California, United States
Unknown Facility
Pasadena, Maryland, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
San Marcos, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Related Publications (1)
Daniels S, Casson E, Stegmann JU, Oh C, Okamoto A, Rauschkolb C, Upmalis D. A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin. 2009 Jun;25(6):1551-61. doi: 10.1185/03007990902952825.
PMID: 19445652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
February 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 9, 2014
Results First Posted
April 23, 2010
Record last verified: 2014-04